Timonen Johanna, Bengtström Marina, Karttunen Pekka, Ahonen Riitta
School of Pharmacy/Social Pharmacy, Faculty of Health Sciences, Kuopio Campus, University of Eastern Finland, POBox 1627, FI-70211 Kuopio, Finland.
BMC Clin Pharmacol. 2010 Oct 22;10:15. doi: 10.1186/1472-6904-10-15.
Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals.
A cross-sectional postal survey was conducted among pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market one year (2004) and five years (2008) after the introduction of GS. Completed questionnaires were returned by 16 original and 7 generic product companies in 2004 (response rate 56%, n = 41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n = 39). Descriptive statistical analyses were performed.
The number of employees (2004: n = 6/16, 2008: n = 7/16) and the amount of prescription medicine marketing (2004: n = 7/16, 2008: n = 8/16) decreased in many of the original product companies after the introduction of GS. GS resulted in problems related to the storage of pharmaceuticals in the original product companies shortly after GS was introduced (p = 0.032 between 2004 and 2008). In the generic product companies, the prescription medicine representatives' visits to pharmacies increased at the beginning of GS (p = 0.021 between 2004 and 2008). In addition, GS caused problems with the storage of pharmaceuticals one year and five years after the reform (2004: n = 4/7, 2008: n = 3/6). The differences between original and generic product companies regarding the impacts of GS were not, however, statistically significant. GS did not affect on the range of sales packages on the market or the research activities of the majority of companies.
The study suggests that GS has had impacts on the activities of pharmaceutical companies in Finland. There were also some differences, although not statistically significant, between the surveyed original and generic product companies regarding the self-reported impacts of GS. More investigations are needed in this field.
芬兰于2003年4月1日开始实行强制仿制药替代（GS）。本研究旨在探讨和比较GS对芬兰主要代表原研药品或仿制药的制药公司活动的影响。从制药公司的角度探讨了GS的自我报告影响，重点关注员工数量、市场上销售包装的范围、营销活动、新药品的研发以及药品储存。
在GS实施一年（2004年）和五年（2008年）后，对在芬兰设有办事处且其药品在芬兰药品市场上可被替代的制药公司进行了横断面邮政调查。2004年，16家原研药品公司和7家仿制药公司返回了完整的问卷（回复率56%，n = 41）；2008年，16家原研药品公司和6家仿制药公司返回了问卷（回复率56%，n = 39）。进行了描述性统计分析。
在许多原研药品公司中，GS实施后员工数量（2004年：n = 6/16，2008年：n = 7/16）和处方药营销量（2004年：n = 7/16，2008年：n = 8/16）有所下降。GS实施后不久，原研药品公司在药品储存方面出现了问题（2004年和2008年之间p = 0.032）。在仿制药公司中，GS开始时处方药代表对药店的拜访增加（2004年和2008年之间p = 0.021）。此外，改革一年和五年后，GS在药品储存方面引发了问题（2004年：n = 4/7，2008年：n = 3/6）。然而，原研药品公司和仿制药公司在GS影响方面的差异无统计学意义。GS对市场上销售包装的范围或大多数公司的研发活动没有影响。
该研究表明，GS对芬兰制药公司的活动产生了影响。在GS的自我报告影响方面，被调查的原研药品公司和仿制药公司之间也存在一些差异，尽管无统计学意义。该领域需要更多的调查研究。
